# K012536: Reprocessed Powered  Arthroscopic Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: Nov 2, 2001 after 87 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K862807 (1986). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971059: Universal Drive System, Linvatec Corp. (1997) Summary page 1.
- K970511: Dyonics Disposable Endoscopic Surgery Blades, Smith & Nephew, Inc. (1997) Summary page 1.
- K953695: Dyonics Disposable Arthroscopic Blades, Smith & Nephew Dyonics, Inc. (1995) Summary page 1.

## Most influential descendants
- K113028: Medisiss Reprocessed Arthroscopic Shavers and Burs (2011), 0 descendants of its own

## Indications for use
Reprocessed powered arthroscopic accessories are intended for use in operative large and small joint arthroscopic procedures and Functional Endoscopic Sinus Surgery (FESS). These accessories are indicated for resection of soft, osseous and cartilaginous tissue, and bone in large and small articular cavities and FESS.

Source page: https://510kreport.com/device/K012536
Methodology: https://510kreport.com/methodology